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Last Updated: December 11, 2019

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Cysteamine bitartrate - Generic Drug Details

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What are the generic drug sources for cysteamine bitartrate and what is the scope of freedom to operate?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has forty-four patent family members in thirty countries.

There are six drug master file entries for cysteamine bitartrate. Two suppliers are listed for this compound.

Summary for cysteamine bitartrate
Recent Clinical Trials for cysteamine bitartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 1
Raptor Pharmaceuticals Inc.Phase 2
Raptor Pharmaceuticals Inc.Phase 2/Phase 3

See all cysteamine bitartrate clinical trials

Pharmacology for cysteamine bitartrate
Synonyms for cysteamine bitartrate
(+/-)-Tartaric Acid
2-aminoethanethiol 2,3-dihydroxysuccinate
27761-19-9
AKOS024332936
AKOS032954217
BC245627
BCP15048
beta-Mercaptoethylamine bitartrate
beta-Mercaptoethylamine hydrogen tartrate
CHEBI:50386
CHEMBL2062263
CTK4G0224
Cysteamine bitartrate (JAN)
D10468
EINECS 248-641-7
Ethanethiol, 2-amino-, tartrate (1:1) (salt)
FT-0696891
MCULE-1129308393
Mercaptamine bitartrate
Procysbi
Procysbi (TN)
QO84GZ3TST
RP103
SCHEMBL49513
UNII-QO84GZ3TST

US Patents and Regulatory Information for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Mylan CYSTAGON cysteamine bitartrate CAPSULE;ORAL 020392-001 Aug 15, 1994 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cysteamine bitartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 C300649 Netherlands   Start Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
1919458 2014C/018 Belgium   Start Trial PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1919458 300649 Netherlands   Start Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 194 50001-2014 Slovakia   Start Trial PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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